4.10.2007EN Official Journal of the European Union L 258/31

COMMISSION DECISION of 24 September 2007 on emergency vaccination of poultry in against low pathogenic avian influenza (notified under document number C(2007) 4393)

(Only the Italian text is authentic) (2007/638/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES, (5) In its scientific opinions on the use of vaccination to control avian influenza issued by the European Food Safety Authority in 2005 (3) and 2007 (4) the Animal Health and Welfare Panel stated that emergency and preventive vaccination against avian influenza is a Having regard to the Treaty establishing the European valuable tool to complement the control measures for Community, that disease.

Having regard to Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (1), and in (6) The outbreaks of low pathogenic avian influenza in Italy particular, Article 54(2) thereof; concern a densely populated poultry area and the epide- miogical situation is still evolving.

Whereas:

(7) The Italian authorities have carried out a risk assessment and identified a particular risk for further spread of the virus in the areas concerned. Italy has, therefore, by letter (1) Directive 2005/94/EC sets out the minimum control dated 7 September 2007, submitted an emergency vacci- measures to be applied in the event of an outbreak of nation plan to the Commission for its approval. avian influenza in poultry or other captive birds.

(2) Under Commission Decision 2005/926/EC of 21 December 2005 on introducing supplementary (8) The Commission has examined that plan together with measures to control infections with low pathogenic Italy and is satisfied that it conforms with the relevant avian influenza in Italy and repealing Decision Community provisions. In the light of the development 2004/666/EC (2) Italy carried out vaccination against of the epidemiological situation in Italy, it is appropriate low pathogenic avian influenza until the end of 2006. to approve the emergency vaccination plan submitted by Italy to supplement the control measures taken by that Member State and to introduce certain restrictions on movements of poultry, hatching eggs of poultry and day-old chicks and certain poultry products. (3) Since May 2007 outbreaks of low pathogenic avian influenza have occurred in parts of Northern Italy and measures in accordance with Directive 2005/94/EC have been taken to control the spread of the virus.

(9) According to the vaccination plan, Italy intends to vaccinate certain poultry categories following the Differ- entiating Infected from Vaccinated Animal (DIVA) (4) In July and August 2007 an increase of low pathogenic strategy using both monovalent vaccines directed avian influenza outbreaks in particular of the subtype H7 against avian influenza virus of subtype H7 and has been observed and further outbreaks of that disease bivalent vaccines against H7 and H5 subtypes. continue to be detected. A small number of outbreaks caused by the low pathogenic avian influenza subtype H5 3 have been reported. ( ) The EFSA Journal (2005) 266, 1-21; Animal health and welfare aspects of Avian Influenza. (4) The EFSA Journal (2007) 489, Scientific Opinion on ‘Vaccination (1) OJ L 10, 14.1.2006, p. 16. against avian influenza of H5 and H7 subtypes in domestic poultry (2) OJ L 337, 22.12.2005, p. 60. and captive birds’. L 258/32EN Official Journal of the European Union 4.10.2007

(10) Only vaccines authorised in accordance with Directive 2. Italy shall carry out the emergency vaccination plan in the 2001/82/EC of the European Parliament and of the areas listed in Annex I (‘the emergency vaccination area’). Council of 6 November 2001 on the Community code relating to veterinary medicinal products (1) or Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community It shall ensure that the emergency vaccination plan is imple- procedures for the authorisation and supervision of mented effectively. medicinal products for human and veterinary use and establishing a European Medicines Agency (2) should be used. 3. The Commission shall publish the emergency vaccination plan on its website.

(11) In addition, surveillance and monitoring of vaccinated and unvaccinated poultry flocks as set out in the emergency vaccination plan should be carried out. Article 3

Vaccines to be used Italy shall ensure that poultry is vaccinated in accordance with (12) The measures provided for in Decision 2005/926/EC are the emergency vaccination plan with one of the following types no longer appropriate and that Decision should therefore of vaccine authorised in accordance with Directive 2001/82/EC be repealed. or Regulation (EC) No 726/2004:

(13) The measures provided for in this Decision are in (a) an inactivated heterologous vaccine of avian influenza accordance with the opinion of the Standing subtype H7; or Committee on the Food Chain and Animal Health,

(b) a bivalent inactivated heterologous vaccine containing both HAS ADOPTED THIS DECISION: avian influenza subtypes H5 and H7.

Article 1 Article 4 Subject matter, scope and definitions Restrictions on movements of poultry 1. This Decision lays down certain measures to be applied in Italy where emergency vaccination is carried out in certain 1. The competent authority shall ensure that poultry that poultry holdings at particular risk for introduction of avian come from and/or originate from holdings in Italy where emergency vaccination has been carried out (‘emergency vacci- influenza, including certain restrictions on movements and ’ dispatch of poultry, hatching eggs of poultry and day-old nation holdings ) are not moved to other parts of Italy or chicks and certain products derived thereof. dispatched to other Member States.

2. This Decision shall apply without prejudice to the 2. By way of derogation from paragraph 1 poultry for measures taken by Italy in accordance with Directive slaughter that come from and/or originate from emergency 2005/94/EC to control outbreaks of low pathogenic avian vaccination holdings may be moved to other parts of Italy or influenza. dispatched to other Member States, where the poultry originate from flocks which:

Article 2 (a) before loading have been examined with favourable results The emergency vaccination plan in accordance with point 1 of Annex II, and 1. The plan for emergency vaccination against low pathogenic avian influenza in Italy, as submitted by Italy to the Commission on 7 September 2007 (‘the emergency vacci- nation plan’) is approved. (b) are dispatched to a slaughterhouse:

(1) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive 2004/28/EC (OJ L 136, 30.4.2004, p. 58). (2) OJ L 136, 30.4.2004, p. 1. Regulation as last amended by Regu- (i) within Italy and are slaughtered immediately upon lation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1). arrival; or 4.10.2007EN Official Journal of the European Union L 258/33

(ii) in another Member State following the agreement of the Article 8 Member State of destination and are slaughtered imme- diately upon arrival. Restrictions on movements of table eggs The competent authority shall ensure that table eggs that come from and/or originate from emergency vaccination holdings are Article 5 moved to other parts of Italy or dispatched to other Member States, only where the eggs: Restrictions on movements of hatching eggs of poultry The competent authority shall ensure that hatching eggs of poultry that come from and/or originate from emergency vacci- nation holdings are moved to other parts of Italy or dispatched (a) originate from flocks which have been examined with to other Member States, only where the hatching eggs: favourable results in accordance with point 2 of Annex II;

(a) originate from flocks which have been examined with (b) are directly transported to: favourable results in accordance with point 2 of Annex II;

(b) have been disinfected before movement or dispatch in (i) a packing centre designated by the competent authority accordance with a method approved by the competent and are packed in disposable packaging and comply authority; with the biosecurity measures required by the competent authority, or

(c) are transported directly to the hatchery of destination; (ii) an establishment for the manufacture of egg products as set out in Chapter II of Section X of Annex III to (d) are traceable within the hatchery. Regulation (EC) No 853/2004 where they are to be handled and treated in accordance with Chapter XI of Annex II to Regulation (EC) No 852/2004.

Article 6

Restrictions on movements of day-old chicks Article 9 The competent authority shall ensure that day-old chicks that come from and/or originate from emergency vaccination Restrictions on movements of poultrymeat, minced meat, holdings are moved to other parts of Italy or dispatched to meat preparations, mechanically separated meat and meat other Member States, only where the day-old chicks: products consisting of or containing poultrymeat 1. The competent authority shall ensure that poultrymeat that comes from and/or originates from emergency vaccination holdings is moved to other parts of Italy or dispatched to other (a) originate from hatching eggs of poultry which satisfy the Member States, only where the meat is: conditions set out in Article 5;

(b) are placed in a poultry house or shed where there are no (a) obtained from poultry that complies with Article 4; resident poultry.

Article 7 (b) produced in accordance with Annex II and Sections II and III of Annex III to Regulation (EC) No 853/2004 and Health certification for intra-Community trade of subject to controls in accordance with Sections I, II, III, consignments of poultry, hatching eggs of poultry and and Chapters V and VII of Section IV of Annex I to Regu- day-old chicks lation (EC) No 854/2004. The competent authority shall ensure that health certificates for intra-Community trade in poultry, hatching eggs of poultry and day-old chicks that come from and/or originate from Italy include the words: 2. The competent authority shall ensure that minced meat, meat preparations, mechanically separated meat and meat products consisting of or containing poultrymeat that come from and/or originate from emergency vaccination holdings ‘The animal health conditions of this consignment are in are moved to other parts of Italy or dispatched to other accordance with Decision 2007/638/EC’. Member States, only where such products are produced: L 258/34EN Official Journal of the European Union 4.10.2007

(a) from meat that complies with paragraph 1; Article 13 Repeal (b) in accordance with Sections V and VI of Annex III to Regu- Decision 2005/926/EC is repealed. lation (EC) No 853/2004.

Article 10

Monitoring and surveillance Article 14 Monitoring and surveillance of vaccinated and unvaccinated Applicability poultry flocks, as set out in the emergency vaccination plan, This Decision shall apply from 24 September 2007 until shall be carried out. 31 March 2008.

Article 11

Reports Article 15 Italy shall submit to the Commission a preliminary report on the implementation of the emergency vaccination plan by Addresses 1 November 2007 at the latest, and thereafter submit This Decision is addressed to the Italian Republic. quarterly reports within one month of the end of each quarter.

The Commission shall ensure that the Standing Committee on the Food Chain and Animal Health is informed of those reports. Done at Brussels, 24 September 2007.

Article 12

Review of measures For the Commission The measures provided for in this Decision shall be reviewed in the light of the development of the epidemiological situation in Markos KYPRIANOU Italy and any new information that becoms available. Member of the Commission 4.10.2007EN Official Journal of the European Union L 258/35

ANNEX I

EMERGENCY VACCINATION AREA

Veneto Region

Verona Province ALBAREDO D'ADIGE area to the south of the A4 motorway CASTEL D'AZZANO area to the south of the A4 motorway area to the south of the A4 motorway ERBÈ area to the south of the A4 motorway MONTEFORTE D'ALPONE area to the south of the A4 motorway PALÙ area to the south of the A4 motorway RONCO ALL'ADIGE ROVEREDO DI GUÀ area to the south of the A4 motorway area to the south of the A4 motorway area to the south of the A4 motorway area to the south of the A4 motorway area to the south of the A4 motorway SONA area to the south of the A4 motorway SORGÀ L 258/36EN Official Journal of the European Union 4.10.2007

VALEGGIO SUL area to the south of the A4 motorway

Lombardy Region Province BRESCIA area to the south of the A4 motorway area to the south of the A4 motorway area to the south of the A4 motorway DELLO area to the south of the A4 motorway LENO LONATO area to the south of the A4 motorway area to the south of the A4 motorway QUINZANO D'OGLIO area to the south of the A4 motorway 4.10.2007EN Official Journal of the European Union L 258/37

Mantova Province CASTIGLIONE DELLE STIVIERE GUIDIZZOLO L 258/38EN Official Journal of the European Union 4.10.2007

ANNEX II

EXAMINATION, SAMPLING AND TESTING PROCEDURES IN RELATION TO MOVEMENTS REFERRED TO IN ARTICLES 4, 5 AND 8 Point 1 Before movement of poultry for slaughter referred to in Article 4(2) the official veterinarian must carry out:

(a) a check of the production and health records of the holding;

(b) a clinical inspection in each production unit, including an evaluation of its clinical history and clinical examinations of the poultry within 72 hours prior to the time of departure with particular attention to the sentinel birds;

(c) the collection of the following samples:

— vaccinated poultry: 20 blood samples for using an appropriate DIVA strategy assay within 72 hours prior to the time of departure;

(d) the collection of the following samples, where the result of the checks and clinical inspection and examinations referred to in (a), (b) and (c) are not satisfactory:

— sentinel birds: 20 tracheal/oro-pharyngeal and 20 cloacal swabs and 20 blood samples for serology using the HI test within 72 hours prior to the time of departure.

Point 2 Before the first movement and thereafter at least every 30 days of hatching eggs and table eggs referred to in Articles 5 and 8, the official veterinarian must carry out:

(a) a clinical inspection of the parent or layer poultry in each production unit, including an evaluation of its clinical history and clinical examinations of the sentinel birds present in those flocks;

(b) the collection of 10 blood samples from sentinel birds. However, if necessary, 20 samples for testing with the iIFA-test shall also be taken.